Safety and Efficacy Study of the QuickFlex Micro Model 1258T Left Heart Pacing Lead

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-05-31

Brief Summary

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This is a prospective, multi-center non-randomized clinical study to evaluate the safety and efficacy of the QuickFlex Micro Model 1258T left ventricular lead in a heart failure patient population. The study will be conducted at a maximum of 20 investigational centers located in the United States and a total of 68 patients will be enrolled.

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Detailed Description

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The investigational left heart lead, QuickFlex Model 1258T, will be implanted with a legally marketed St. Jude Medical cardiac resynchronization therapy implantable cardioverter defibrillator (CRT-D) device.

Patients will be followed at Pre-Discharge, 1-Month, 3-Month,and then every 6 months until the end of the study.

Conditions

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Heart Failure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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QuickFlex micro 1258T left heart lead

Group Type EXPERIMENTAL

QuickFlex Micro Model 1258T Left Heart Lead

Intervention Type DEVICE

Implantation of QuickFlex Micro 1258T left heart lead in combination with a CRT-D system.

Interventions

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QuickFlex Micro Model 1258T Left Heart Lead

Implantation of QuickFlex Micro 1258T left heart lead in combination with a CRT-D system.

Intervention Type DEVICE

Other Intervention Names

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Model 1258T left heart pacing lead

Eligibility Criteria

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Inclusion Criteria

* Approved indication for CRT-D system

Exclusion Criteria

* Previous cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 3 months of enrollment
* Previous left ventricular (LV) lead implant
* Have had a heart attack,unstable angina or cardiac revascularization (percutaneous transluminal coronary angioplasty (PTCA),coronary artery bypass grafting (CABG), Stent) within 40 days prior to enrollment

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No